Radiopaque abdominal pack

ABSTRACT

A radiopaque abdominal pack is formed by interweaving occasional warp or filling yarns, or both, in a multilayered open mesh fabric and sealing at least one of the cut edges of the fabric with a soft, flexible polymeric sealant containing a radiopaque substance such as barium sulfate.

Mmeel States Patent 11 1 u 11 3,756,241 Patience 1 Sept. 4, 1973 [54] RADIOPAQUE ABDOMINAL PACK 3,133,538 5/1964 Pratt et al. 128/296 3,190,289 6/1965 Patience 128/296 [75] Inventor. Donald Patience, Barrington, Ill. 3'491802 1/1970 Mortensen et a1 128/296 [73] Assignee: The Kendall Company, Walpole, 3,542,027 11/1970 HlgglllS 128/284 Mass 3,698,393 10/1972 Stone 128/296 [22] Filed: June 191 1972 Primary ExaminerCharles F. Rosenbaum [21] Appl. No.: 264,367 Attorney lohn F. Ryan 52 us. c1. 128/296 [57] ABSTRACT [51] Int. Cl. A61f 13/00 A radiopaque abdominal p i f rmed by interweav- [58] Field of Search 128/156, 284, 286, g Occasional p or filling y or both, in a m i- 123/237 290 296 layered open mesh fabric and sealing at least one of the cut edges of the fabric with a soft, flexible polymeric [56] Ref n Cit d sealant containing a radiopaque substance such as barium sulfate.

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RADIOPAQUE ABDOMINAL PACK BACKGROUND OF THE INVENTION This invention is concerned with surgical laparotomy sponges commonly referred to as ABD packs, or abdominal packs. ABD packs are often used in surgical procedures involving the opening of the abdominal wall by surgical incision whereby body organs and delicate membranes and tissues are exposed. These delicate body members when exposed to the air are subject to radically different environmental conditions from those normally encountered in the moist warmth of the body. It is considered good surgical procedure, therefore, to simulate an environment more nearly approaching the natural environment by using ABD packs moistened with warm saline solution. Such moistened packs are inserted into the cavity to protect and isolate those interior body organs and tissues not directly involved from accidential impact and environmental hazards of the immediate operative area. In the operative area itself ABD packs, either dry or only slightly moistened, are used to sponge and soak up any surplus body fluid present.

ABD packs have evolved over many years of surgical practice. Presently used ABD packs are an attempt to retain both the advantages of thin, soft and flexible single layers and the absorptive cushioning and insulating properties of thicker padlike structures. As a result, the ABD pack has traditionally been formed of multiple layers of thin, soft, low-count gauzelike material which are unified along fairly widely separated lines usually extending longitudinally or transversely but in some instances in both directions. Unification has been accomplished either by lines of machine stitching whether the pack is formed of separated layers or, as is more common, by folding a single width of fabric, or by interweaving yarns in various layers of the multi-ply fabric as set forth in U. S. Patent application Ser. No. 250,238, filed May 4, 1972, of common assignee, a continuation-in-part of Ser. No. 093,191 filed Nov. 27, 1970, now abandoned.

Pieces of yarn separate readily from the cut edges of open mesh low count fabrics, and their presence of course is very undesirable in a sponge or pack intended for use inside a body cavity. Pieces of yarn are not digested or assimilated by body fluids, butinstead the human system treats such yarns as foreign bodies, and attempts to encapsulate them, leading to pain and irritation, or more severe syptoms, in the patient. It has been the universal practice, therefore, to fold in the raw cut edges of a multi-layered abdominal pack, and to stitch the folded-in edges securely, to prevent ravelmg.

An even more severe foreign body reaction occurs when a whole ABD pack is inadvertently left inside a body cavity after an operation is completed. To guard against such an occurrence, packs used in an operation are rigorously counted, and the count is checked as each pack is removed from the body cavity. As an additional precaution, a loop of woven tape, usually colored, is frequently attached to a corner of a pack, to be left hanging out of the incision while the pack is in the' body.

Despite such safety measures, packs were occasionally lost, especially when an unexpected emergency disturbed the normal operative routine. The counting of packs is subject to human error. It has become increasingly common, therefore to provide ABD packs with a flexible, non-irritating insert or tell-tale which is opaque to X-rays. Thus, in case of a disputed or nontallying pack count in the operating room, or in case of unexpected or unexplainable post-operative discomfort on the part of the patient, a portable X-ray unit is brought to the patient and an X-ray exposure reveals the presence or absence of a lost pack. A negative plate is reassurance to the surgeon that he and his operative team have not been guilty of negligence.

Many years ago, hospitals occasionally sewed into the body of an ABD pack a piece of metal foil, or even a metal washer, for X-ray identification. This was tedious, expensive, and interfered with launderability. Commercially available packs have supplanted such expedients with either a tab or insert of flexible polymeric material, or a thread or filament of such material, the polymer in each case being loaded or filled with a substance opaque to X-rays, commonly barium sulfate.

The attachment of such inserts into the body of an ABD pack involves sewing, interweaving, or some sort of fixation process, which again adds to the cost of the pack.

Therefore, while the present radiopaque ABD packs are functionally satisfactory, they have been relatively expensive compared with other sponges. That fact, and their relatively large size (12" X 12", 8" X 36" and 18'' X 8"), has made reclaiming such packs a requisite matter. It is a rather general practice, therefore, to launder, wrap in sterilizing cloths, and resterilize such packs and reuse them. Obviously, reclaiming such packs is accomplished at some expense, a great deal of which is labor cost. What has been needed and what has not been attainable until this invention is a gauzelike radiopaque ABD pack with all the desirable features of presently used packs but of such construction as to reduce the cost of manufacture. Such packs, normally, could be disposed of (possible without economic penalty) where the costs of reclaiming are high.

SUMMARY OF THE INVENTION It is an object of the present invention to provide an X-ray detectable ABD pack comprising a plurality of plies of fabric, the edges of said pack being sealed into ravel-resistant condition by a soft, non-irritating polymeric sealing material, the sealing material applied to a substantial portion of at least one of said cut edges containing a substance which is opaque to X-rays.

It is a further object of the invention to provide such a pack wherein the polymeric component of the sealant is a copolymer of vinyl chloride and vinyl acetate.

Other objects of the invention will be more readily understood from the following description and drawings, in which FIG. 1 is a front elevation of a typical ABD pack of this invention.

FIG. 2 is a cross-sectional view of the. pack of FIG. 1, taken along the line 2---2.

FIG. 3 is a front elevation of another embodiment of the invention. t

DETAILED DESCRIPTION OF THE INVENTION Referring to the drawings:

The woven ABD pack 10 illustrated in FIG. 1 is cut away to show the ply structure. A top ply 11, an intermediate ply 21, and a bottom ply 15 are joined together by a selvage edge 19, three ravel-resistant sealed edges 12, 13, and 14 and by tie-ins 16, 17, and 18 running warpwise. The tie-ins are preferably effected by setting the weave pattern so that the tie-in yarns are common to a plurality of the plies of the fabric, or they may be effected by sewing.

A substantial part, and preferably all, of at least one sealed edge, such as 13, is sealed with a soft, flexible polymeric sealant containing barium sulfate or a similar non-toxic substance opaque to X-rays, the sealed edge 13 thus being different in composition from the sealed edges 12 and 14.

Such a radiopaque sealant may be effected by applying to the interwoven layers of fabric, at suitable longitudinal intervals, a strip of molten or softened thermoplastic polymeric film containing barium sulfate, pressing the softened film into and through the layers of fabric, allowing the film to resolidify by cooling, and then slitting or cutting the fabric in the sealed area to form individual packs.

A wide variety of soft, flexible thermoplastic polymers are capable of being loaded with a large amount of barium sulfate without losing their film-forming characteristic. Olefinic polymers such as polyisobutylene are one class, but for ease in handling and good adhesive properties it is preferred to use a copolymer of vinyl chloride (50% 86%) and vinyl acetate (50% 14% compounded with U. S. P. barium sulfate in a ratio of 4 5 parts polymer to 6 5 parts sulfate. In order to impart greater thermoplasticity to the polymer, it is preferred to plasticize it with 30 to 100 parts of a plasticizer such as dioctylphthalate or di-isooctylphthalate, depending on the particular ratio of chloride-acetate present in the base polymer.

Although other methods of applying a radiopaque edge sealant may be employed, such as stencil spraying or the application of a solvent solution or plastisol of the polymer, the longitudinal seal is preferably made by the application of a softened film, as described above. In making the transverse seals 12 and 14, the machine and method described in U. S. Pat. No. 3,506,518, assigned to Deering Milliken Research Corporation, is preferably utilized. The edges 12 and 14 may be made of radiopaque sealant if desired, but it is generally found that only a single radiopaque sealed edge, such as 13, provides excellent identification of an ABD pack on an X-ray plate.

FIG. 3 illustrates another embodiment 25 of the invention, the pack having two plies 26 and 27 with selvage edges 34 and 35 and sealed ravel-resistant edges 36 and 37. In this embodiment, the woven tie-ins 29,

30, 31, 32, and 33 extend warpwise, while tie-in 28 extends weftwise. The sealed edge 36 is sealed with a radiopaque sealant, while the edge 37 may optionally be sealed with a non-opaque sealant.

In general it has been found that the application of a film of radiopaque vinyl copolymer of from 2 to 4 mils in thickness gives good radiopacity, and although soft and flexible will survive repeated laundering.

In interweaving the plies of fabric, preferably single warp yarns, or weft yarns, or both, are woven so as to alternate between layers, in a manner well known in the weaving art and as shown in FIG. 2, where warp yarns l6, l7, and 18 unite the three gauze layers 11, 21, and 15 at intervals intermediate between the selvage edge 19 and the radiopaque sealed cut edge 13. The tie-in yarn 28 of FIG. 3 is a weft or filling yarn, the deployment of which will also be readily understood by those skilled in the weaving art.

The tie-ins may be at any of the usual intervals presently used in uniting the layers intermediate the edges of conventional ABD packs in which the fabric layers are stitched together. In general, tie-ins at from about one inch to five inches intervals in either or both directions are entirely satisfactory with about three inches being the most common interval. It is to be understood that the closer the tie-ins are, the less the pack has the characteristic thinness, softness and flexibility of single layer fabric, and the more it has the absorptive, cushioning and insulating properties of quilted padlike structures.

Having thus described my invention, I claim:

1. A radiopaque abdominal pack with ravel-resistant edges which comprises a multiplicity of interdependent edge-joined plies of open-meshed absorbent fabric,

said interdependent plies being united along at least one path intermediate the edges of said pack by at least one yarn which is common to a plurality of plies,

the cut edges of said pack being sealed to ravelresistant condition by a non-toxic, flexible, thermoplastic sealant,

a substantial portion of the sealant on at least one edge of said pack containing a substance which is opaque to X-rays.

2. The pack according to claim 1 in which the polymeric sealant is a plasticized copolymer of vinyl chloride and vinyl acetate and the substance opaque to X- rays is barium sulfate.

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2. The pack according to claim 1 in which the polymeric sealant is a plasticized copolymer of vinyl chloride and vinyl acetate and the substance opaque to X-rays is barium sulfate. 